VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in diabetes and sexual health, announced that it has initiated an open label safety study (TA-314) with its investigational drug, avanafil, in males with erectile dysfunction (ED).

VIVUS also announced today that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled phase 3 study of avanafil in men with a history of generalized ED and the first of several planned phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the study. Top-line results of REVIVE are expected in the fourth quarter of 2009.v
Avanafil, a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 (PDE5) inhibitor, is VIVUS’ investigational product for the treatment of ED. The phase 3 program for avanafil is funded through a $30 million collaboration with Deerfield Management.

“We continue to make excellent progress on the avanafil phase 3 program, and are pleased with the rapid rate at which we accrued patients in our first pivotal study, REVIVE,” commented Charles Bowden, MD, senior director of clinical development at VIVUS. “Initiation of the TA-314 safety study is a critical step in advancing avanafil toward an NDA filing. We are confident that avanafil will provide a much needed new option for the millions of men living with ED, and we look forward to announcing data from both of these studies later this year and next.”

The open-label study is being conducted in approximately 600 patients across 40 U.S. centers. Patients completing either the 12-week REVIVE or REVIVE-Diabetes studies are eligible to participate in TA-314. The goal of the TA-314 study is to collect safety data on at least 300 patients for 6 months and at least 100 patients for 12 months. Results of the TA-314 study are expected to be available by mid-2010.

“Initiation of the avanafil safety study is an important step in the development of the drug and demonstrates continued momentum at VIVUS,” added Leland Wilson, president and chief executive officer of VIVUS. “We’re very pleased with the progress we have made across our entire pipeline. We look forward to several significant milestones in the second half of this year, including results from two phase 3 obesity trials of our lead product Qnexa as well as data from the REVIVE trial of avanafil and participation in several upcoming medical meetings.”

About VIVUS

VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company’s lead product in clinical development, Qnexa(TM), is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2008 and periodic reports filed with the Securities and Exchange Commission.

Source: VIVUS, Inc

Chlamydia one of the most frequently reported sexually transmitted diseases in the North America. Estimates are that more than 89 million people worldwide are currently infected with the disease. It is caused by the bacterium Chlamydia trachomatis.

Chlamydia can be transmitted through oral, vaginal, or anal sex. It can also be passed from a mother to her baby during a vaginal birth. Anyone who is sexually active is at risk for contracting chlamydia, and the greater the number of sexual partners, the greater the risk. Even close physical contact can cause transmission if bodily fluids are exchanged. Penetrating sex is not required to contract or spread chlamydia.

The chlamydia bacterium is similar to gonorrhea in the symptoms it produces and the way it is spread. Like gonorrhea, it can live in the cervix, urethra, throat, and rectum. Infected persons, both men and women, may lack any symptoms and can spread the disease unknowingly to other sexual partners.

Chlamydia symptoms (Men and Women)

Chlamydia symptoms usually become evident in one to three weeks after infection. However, chlamydia is one of the silent STDs because some people show no symptoms at all. It is estimated that about 75 percent of women and 50 percent of men exhibit no signs of the disease.

In women, chlamydia symptoms include vaginal discharge, burning or painful urination, abdominal pain, and lower back pain, pain during intercourse, fever, nausea, and vaginal bleeding between periods. In men, common symptoms include burning or painful urination, penile discharge, burning or itching around the opening of the penis, and swelling of the testicles.

Chlamydia Treatment

If used properly, antibiotics can completely cure this sexually transmitted disease. Chlamydia treatment can be achieved in a single dose with the antibiotic azithromycin. Another antibiotic that is commonly used is doxycycline but repeated doses over one week are required.

Although there is typically no resistance to antibiotics by the chlamydia bacterium, recent discoveries of antibiotic resistant strains have been made. It is unclear whether these strains are present in humans, and further research needs to be conducted. However, this could be an emerging problem for anyone who contracts or is at risk for contracting the disease.

Complications

When left untreated, this sexually transmitted disease can result in serious complications. PID occurs when the infection travels upwards into the female reproductive organs. This complication develops in nearly 40 percent of women who do not seek treatment. The damage caused by PID can lead to infertility, chronic pelvic pain, and potentially fatal ectopic pregnancies. Women infected with chlamydia are also up to five times more likely to contract HIV if exposed, than women with a healthy reproductive system.

Like gonorrhea, chlamydia is also responsible for an increased risk of premature birth. The infant is also likely to contract the infection while traveling through the birth canal. This can lead to serious eye injury or pneumonia. However, all newborns are treated with eye drops that kill the chlamydia bacteria to prevent serious damage to the eyes. This practice is routine because so many women carry the infection unknowingly and without symptoms.

In men, chlamydia complications are rarer, but can occur. Infection can spread to the epididymis, or the tube that carries sperm from the testes. This can lead to pain, fever, and in very rare cases, sterility. Other rare side effects of this sexually transmitted disease includes skin lesions, inflammation of the eyes, arthritis, and meningitis.

Prevention

As with all sexually transmitted diseases, chlamydia can be prevented most easily by abstaining from sexual intercourse completely, or engaging in sexual activity with one monogamous partner who has been tested and confirmed negative for the disease. Latex condoms, when used properly, can reduce the risk of transmission, although it cannot completely remove the risk.

To prevent the risk of serious complications, it is recommended that you undergo regular screenings for all STDs, including chlamydia. Any genital symptoms such as soreness, itching, burning, or bleeding, should be immediately evaluated by a qualified medical professional.

I recently read a post on the Drugs.com forum (see http://www.drugs.com/forum/need-talk/i-feel-sometimes-erectile-dysfunction-need-help-52430.html)

This made me want to post a similar post on here.  The original question was about an individual who was experiencing symptoms of ED.

Erectile Dysfunction can be caused by several different reasons.

Low testosterone - have you ever used steroids?  What hormone medications are you taking?  Do you eat healthy and work out / exercise often?   Lifting weights and working out will increase your sex drive.

Medications - are you an anti-depressant, such as Paxil?  Many medications can cause impotence.

Sometimes, it is important to try to identify the source of the problem before you try to treat it.

If you do determine that you can safely take an ED medication, then order it online.  I prefer to order mine online for convenience and price (after co-pays)… but you should probably talk to your doctor before you try anything.

I order mine from http://www.generic-ed-pharmacy.com or from http://www.drugpricegrabber.com for a larger product list.

There are certain medications that are not safe to mix and certain conditions might increase your risk (i.e. high BP, heart conditions, etc.).

Honestly, your ED might be a result of a poor diet and general health. If you begin living a healthier life, working out, etc…. your natural testosterone levels will rise and your sex drive might increase. There’s no way to tell unless your dr. examines you and admittedly, most doctors will just write you the prescription without a second thought. You might benefit from some of the articles on this blog

As we mentioned in previous article, premenstrual syndrome effects over 70% to 90% of women before menopause in US and less for women in Southeast Asia because of their diet. Premenstrual syndrome (PMS) occurrence have more than double over past 50 years due to the acceptance of its as medical condition and caused by unhealthy diet with high in saturated food. Premenstrual syndrome is defined as faulty function of ovaries related to women menstrual cycle, it effects the women physical and emotional state and sometimes interference with daily activities as resulting of hormone fluctuation. The syndrome happens in one or two weeks before menstruation and then declining when the period starts. It is said the symptoms can be so severe that between 10-15% of women have to take time off work, costing businesses millions of dollars a year. In this article, we will discuss what exhibits insomnia to cause PMS.

1. Mineral deficiency
Calcium, magnesium and silicon are essential for women during menstrual cycle because they have a calming effects for the nervous system. Imbalance or deficiency of calcium, magnesium and silicon increase the tension of the brain’s cell resulting in insomnia.

2. Vitamin deficiency
Women with PMS are found to have low levels of vitamin B6 which is vital to convert trytophan to serotonin. Deficiency of vitamin B6 interferes the production of serotonin resulting in lessening the production of melatonin, a vital hormone in promoting a good nigh sleep.

3. Alcohol
Alcohol not only damages the liver in fat and protein metabolism, it also increases the tension of nervous system. Limit intake of less than one cup of wine everyday will helps to reduce the symptoms of insomnia.

4. Caffeine
Caffeine may helps to increase nervous system function but it may causes nervous tension and vitamin B6 deficiency as resulting of caffeine stimulating. It also causes unbalance of production of serotonin and melatonin hormone resulting in increasing the nervous tension leading to insomnia.

5. Low levels of melatonin
Melatonin is hormone which helps to regulate the sleep pattern of our body. some women with PMS found to have low levels of melatonin before period caused by low levels of serotonin and trytophan. Intake of food with high in serotonin and trytophan will help.

5. Insulin irregularity
Researchers exam the inter relationship between insomnia and insulin fluctuation found out that improving insulin balancing will helps to improve the sleep pattern and via versa.

To read the series of PMS,please visit
http://pre-menstrualsyndrome-pmsi.blogspot.com/
To read all articles of women health, please visit
http://medicaladvisorjournals.blogspot.com/

UroToday.com - The etiology of multiple sclerosis (MS)-emergent erectile dysfunction (ED) is still matter of debate, since both organic and psychological factors have been implicated. There is an association between sexual dysfunction (SD) and destructive lesions in the pons, in MS patients. Central and peripheral nerves systems play a key role in the erectile process. The innervation of the penis is both autonomic (sympathetic and parasympathetic) and somatic (sensory and motor). Pudendal nerves have a central role in erection. Tactile stimulation of the penile shaft activates parasympathetic fibers, which travel in the pudendal nerve and function through the spinal reflex arc from S2 to S4. Neural signals originating in the brain are transmitted to a thoracolumbar erection center and trigger the psychogenic erection associated with either fantasy or viewing erotic material. In addition, the ischiocavernosus and bulbospongiosus striated muscles, which located at the penile crus, are innervated by the motor pudendal nerve. Contraction of these muscles has a definite, contributory role in penile erection. Therefore, erection is a neurovascular event, and any disease or dysfunction affecting the brain, spinal cord, or cavernous and pudendal nerves can induce ED. With respect to placebo, sildenafil produced a 16% greater success rate for vaginal penetration, and a 15% greater rate for successful intercourse. For satisfaction with erection hardness, and satisfaction with the sexual experience, sildenafil did not produce two-fold greater rates. For all efficacy variables, sildenafil had similar or slightly greater scores compared with placebo.

Although some clinical trials have demonstrated an overall success rate of greater than 70%, certain patients will be refractory to treatment with sildenafil. Sildenafil acts a potentiator of local mediators to maintain smooth muscle relaxation and thus cannot act in the absence of intact penile innervation. In this study, most of the participants had abnormal pudendal nerve cortical somatosensory evoked potentials (PEPs). The incidence of ED after non-nerve sparing radical retropubic prostatectomy is up to 97%. This is due to cavernosal nerve damage. A poor response to sildenafil in postoperative patients with unilateral or non-nerve-sparing radical retropubic prostatectomy has been demonstrated. Direct-acting medications might be expected to be efficacious in nonresponders who have nerve injury or nerve damage. Fifty percent of the post prostatectomy patients who had failed with sildenafil, reported improved EF with intraurethral alprostadil.

Sexual dysfunction is a frequent disorder associated to MS, which contributes to the worsening of quality of life of these patients. During the course of MS, prevalence of SD becomes increasingly more common, affecting, after 10 years of disease duration, 40-70% of patients.

Interactions between neural structures are essential to all phases of human sexual response and functioning. Neurophysiological studies give invaluable information on the involvement of the parts of the nervous system that are essential in the control of sexual function. The pudendal nerve and its terminal branch (dorsal nerve of the penis) provide somatosensory innervation to the genitalia in men. Sensory pathways, which are important in reflexogenic erections, transmit information to the CNS via the dorsal penile nerve and the pudendal nerve. Therefore, a neurophysiological test that assesses the pudendal nerve function such as the PEPs, has great value in an objective evaluation of SD.

We did not recommend second or third type PDE-5 inhibitors for sildenafil non-responders. All three FDA approved PDE-5 inhibitors are targeting the same site of action. Studies from the industry tend to favor preference for their own drug, whereas independent studies tend to show no major difference in preference. Multiple well-designed studies have shown that, all three available PDE-5 inhibitors, have a very similar efficacy and safety profile. In our experiences, well-educated sildenafil non-responders, seldom respond to other type of PDE-5 inhibitors.

Written by M.R Safarinejad, MD as part of Beyond the Abstract on UroToday.com

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
www.urotoday.com

Copyright © 2008 - UroToday

Dr. J. Francois Eid has performed more internal penile implant surgeries than anyone in the world and has built a reputation for excellence in the treatment of erectile dysfunction (ED). After examining the latest generation of Inflatable Penile Prosthesis (IPP) and Artificial Urinary Sphincter (AUS) technologies from American Medical Systems (AMS) and Coloplast Corporation, reviewing pertinent studies, and drawing on his 20 years of experience performing penile prosthesis surgery and overseeing his patients’ recuperation and subsequent training in operating the devices, Dr. Eid has high praise for the recent improvements. Updates have been made to the IPP pumps offered by both AMS and Coloplast, as well as to the CX and LGX cylinders offered by AMS. Also, AMS has added an antibiotic coating to its AUS.

Momentary Squeeze (MS) Pump - AMS

AMS’s Momentary Squeeze (MS) Pump was first introduced nearly two years ago, and Dr. Eid has implanted it with great success in patients suited to the CX-cylinder and LGX-cylinder versions. (The LGX model offers the potential for increased penile length in patients complaining of penile shortening after radical prostatectomy.) Both cylinders now feature redesigned proximal ends. At only 9.5mm in diameter, the ends allow for significantly easier insertion for patients with fibrotic proximal corporal bodies.

The MS Pump’s advantages include a smaller profile (which enables a more discreet placement) and one-touch deflation. However, this quality can result in operational difficulties with inflation (more difficult to get a hold of within the scrotum) and deflation (small button can initially be difficult to find). In addition, its new lockout valve has the advantage of preventing auto-inflation (potentially embarrassing and/or painful), but can at times make it difficult to initiate inflation. For these reasons, Dr. Eid recommends this pump for the younger patient with an average-sized penis.

Tactile Pump (700 CX Series) - AMS

“The AMS 700 CX Series with the Tactile Pump remains my prosthesis of choice for the older patient where pump concealment is not an issue,” says Dr. Eid. “This pump is large, easily palpable, remains the softest to inflate and has a very large deflation footprint, which is quickly recognized by the patient.” The Tactile pump is not available with the LGX cylinders.

Titan Pump - Coloplast

The FDA approved the improvements to the pump component of the Coloplast Titan prosthesis in July 2008. Although the cylinders and reservoir remain the same as the previous model, the pump now features a one-touch-release (OTR) deflation valve — easy for patients to locate and operable with one hand. In addition, the pump offers a non-bulky, low-profile size; enhanced silicone for higher threshold “tear strength” (likely to result in increased product durability, an issue with previous versions); and an overall simplicity likely to decrease repeat office visits, phone calls, and repeat training time. From a hospital standpoint, intraoperative prep of the device provides for easier priming of the implant system (the removal of excess air prior to filling) and may reduce slightly the overall intraoperative time.

“This remains a great device for the patient with a larger penis,” says Dr. Eid, “as these are the only cylinders that will expand to 22mm girth.” In addition, only Titan cylinders are available in lengths of 24cm, 26cm and 28cm.

Although the pump is easily identified and operated by patients, the small size of the deflation valve sometimes requires a longer learning curve.

In a recent study (”Evaluation of Three Penile Prosthesis Pump Designs in a Blinded Survey of Practitioners,” Urologic Nursing, 2008), 32 medical professionals, all familiar in teaching the operation of penile implants to patients, reviewed currently available penile pumps. The blindfolded reviewers, examining the pumps under time constraints through mock scrotal sacs, were asked to rate device:

– ease of location of deflation valve
– ease of inflation
– ease of deflation, and
– anticipated ability to train patients in clinical setting.

The Titan OTR pump design performed very well and “consistently demonstrated a significant advantage in subject preference.” (Quallich, Ohl & Dunn, 2008, p. 5).

Artificial Urinary Sphincter - AMS

AMS has improved the AUS by coating the device surface with inhibizone. This is the same antibiotic coating (Rifampin and Minocin) currently available on the IPP that has dramatically reduced infection rates since its introduction in 2001. In combination with Dr. Eid’s self-developed “no-touch” surgical technique, which eliminates direct and indirect contact between the prosthesis and the patient’s skin (the origin of most infections), he believes the new coating will offer additional protection against the most common pathogens responsible for sphincter infections.

Dedicated to Patient Education

Dr. Eid has developed a website http://www.UrologicalCare.com dispelling common misconceptions about penile implant surgery. Having performed over 3,000 penile implant surgeries (the most worldwide), Dr. Eid knows what a remarkable and positive difference the treatment can make in a man’s life. Between retaining a normal penis look and feel, employment of multiple techniques for preventing infection, and steady diminishment of pain until it is completely gone within 2-4 weeks, penile implant surgery has proven to be an effective treatment for many men, resulting in normal, healthy and productive lives.

About J. Francois Eid, M.D, and UrologicalCare.com

Dr. Eid is the director and founder of Advanced Urological Care in New York City. He is also a Clinical Associate Professor of Urology at Cornell University. Dr. Eid is one of the foremost specialists in urological prosthetic reconstruction and performs over 300 internal penile implants per year. Dr. Eid leads workshops on penile prosthesis surgeries worldwide. More information about Dr. Eid and his expertise with erectile dysfunction treatment, penile prosthesis implantations and artificial urinary sphincters can be found on his website, http://www.UrologicalCare.com.

UrologicalCare.com

Rexahn Pharmaceuticals, Inc. (NYSE Alternext US: RNN), a leader in development of innovative therapeutics for life-threatening and life-debilitating diseases, announced the completion of enrollment in its Phase IIa clinical trial evaluating ZoraxelTM for treatment of Erectile Dysfunction (ED). The Company expects to have preliminary study results in March 2009.

Zoraxel is being developed as an orally administered tablet for on-demand use, and is one of three compounds being developed by Rexahn as a part of the Company’s clinical stage drug pipeline. In addition to lacking the common side effects associated with many popular ED treatments, Zoraxel has also been shown to significantly improve sexual arousal, erection, and release in disease model studies.

Dr. Chang H. Ahn, Chairman and CEO of Rexahn commented, “It has been our stated goal to move our three highly-marketable compounds successfully through the clinical trial process, and the completion of patient enrollment in the Zoraxel trial represents another steady step in the right direction for Rexahn. This milestone is especially meaningful to us, as we have long believed that our ED compound is a safer and more effective alternative to currently marketed drugs for ED. We look forward to examining and sharing the preliminary data with our shareholders and stakeholders in the near future.”

The Zoraxel Phase IIa trial is a double blind, placebo-controlled, dose ranging study conducted at three U.S. study sites in up to 40 male subjects ages 18 to 65 with ED for six months. Main study endpoints for the 8-week treatment period were the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF), both of which are validated surveys for assessing erectile function. Planning is underway for initiation of Phase IIb clinical studies.

About ZoraxelTM

ZoraxelTM is being developed as an orally administered, on-demand tablet. It has a well established and excellent safety record in humans and appears to lack severe side effects associated with standard of care phosphodiesterase (PDE-5) inhibitor ED drugs, such as priapism, severe hypotension, myocardial infarction, sudden death, increased intraocular pressure and sudden hearing loss. ZoraxelTM is a centrally acting, dual enhancer of neurotransmitters in the brain, whereas PDE-5 inhibitors only target end organ erectile function and work in peripheral blood vessels. In preclinical animal models, ZoraxelTM has significantly improved all three functions of sexual activity, i.e. sexual arousal, erection, and release, and may be a more effective ED treatment for patients who are responsive or unresponsive to PDE-5 inhibitors.

About Erectile Dysfunction (ED)

ED is defined as the consistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse. ED affects up to 30 million estimated men in the United States, with 52% of men between the ages of 40 and 70 reporting difficulty with erectile function. By the year 2025, it is estimated that 322 million men worldwide will suffer from some degree of sexual dysfunction.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. For more information please visit http://www.rexahn.com

Safe Harbor

This press release contains forward-looking statements. Rexahn’s actual results may differ materially from anticipated results, and expectations expressed in these forward-looking statements, as a result of certain risks and uncertainties, including Rexahn’s lack of profitability, its auditor’s going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn’s development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn’s product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn’s claims; demand for and market acceptance of Rexahn’s drug candidates; Rexahn’s reliance on third party researchers and manufacturers to develop its product candidates; Rexahn’s ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. Rexahn assumes no obligation to update these forward-looking statements.

Rexahn Pharmaceuticals, Inc.

Dr. J. Francois Eid has
performed more internal penile implant surgeries than anyone in the
world and has built a reputation for excellence in the treatment of
erectile dysfunction (ED). After examining the latest generation of
Inflatable Penile Prosthesis (IPP) and Artificial Urinary Sphincter
(AUS) technologies from American Medical Systems (AMS) and Coloplast
Corporation, reviewing pertinent studies, and drawing on his 20 years
of experience performing penile prosthesis surgery and overseeing his
patients’ recuperation and subsequent training in operating the
devices, Dr. Eid has high praise for the recent improvements. Updates
have been made to the IPP pumps offered by both AMS and Coloplast, as
well as to the CX and LGX cylinders offered by AMS. Also, AMS has
added an antibiotic coating to its AUS.

Momentary Squeeze (MS) Pump - AMS

AMS’s Momentary Squeeze (MS) Pump was first introduced nearly two
years ago, and Dr. Eid has implanted it with great success in patients
suited to the CX-cylinder and LGX-cylinder versions. (The LGX model
offers the potential for increased penile length in patients
complaining of penile shortening after radical prostatectomy.) Both
cylinders now feature redesigned proximal ends. At only 9.5mm in
diameter, the ends allow for significantly easier insertion for
patients with fibrotic proximal corporal bodies.

The MS Pump’s advantages include a smaller profile (which enables a
more discreet placement) and one-touch deflation. However, this
quality can result in operational difficulties with inflation (more
difficult to get a hold of within the scrotum) and deflation (small
button can initially be difficult to find). In addition, its new
lockout valve has the advantage of preventing auto-inflation
(potentially embarrassing and/or painful), but can at times make it
difficult to initiate inflation. For these reasons, Dr. Eid
recommends this pump for the younger patient with an average-sized
penis.

Tactile Pump (700 CX Series) - AMS

“The AMS 700 CX Series with the Tactile Pump remains my prosthesis of
choice for the older patient where pump concealment is not an issue,”
says Dr. Eid. “This pump is large, easily palpable, remains the
softest to inflate and has a very large deflation footprint, which is
quickly recognized by the patient.” The Tactile pump is not available
with the LGX cylinders.

Titan Pump - Coloplast

The FDA approved the improvements to the pump component of the
Coloplast Titan prosthesis in July 2008. Although the cylinders and
reservoir remain the same as the previous model, the pump now
features a one-touch-release (OTR) deflation valve — easy for
patients to locate and operable with one hand. In addition, the pump
offers a non-bulky, low-profile size; enhanced silicone for higher
threshold “tear strength” (likely to result in increased product
durability, an issue with previous versions); and an overall
simplicity likely to decrease repeat office visits, phone calls, and
repeat training time. From a hospital standpoint, intraoperative
prep of the device provides for easier priming of the implant system
(the removal of excess air prior to filling) and may reduce slightly
the overall intraoperative time.

“This remains a great device for the patient with a larger penis,”
says Dr. Eid, “as these are the only cylinders that will expand to
22mm girth.” In addition, only Titan cylinders are available in
lengths of 24cm, 26cm and 28cm.

Although the pump is easily identified and operated by patients, the
small size of the deflation valve sometimes requires a longer learning
curve.

In a recent study (”Evaluation of Three Penile Prosthesis Pump
Designs in a Blinded Survey of Practitioners,” Urologic Nursing,
2008), 32 medical professionals, all familiar in teaching the
operation of penile implants to patients, reviewed currently
available penile pumps. The blindfolded reviewers, examining the
pumps under time constraints through mock scrotal sacs, were asked to
rate device:

— ease of location of deflation valve
— ease of inflation
— ease of deflation, and
— anticipated ability to train patients in clinical setting.

The Titan OTR pump design performed very well and “consistently
demonstrated a significant advantage in subject preference.”
(Quallich, Ohl & Dunn, 2008, p. 5).

Artificial Urinary Sphincter - AMS

AMS has improved the AUS by coating the device surface with
inhibizone. This is the same antibiotic coating (Rifampin and Minocin)
currently available on the IPP that has dramatically reduced infection
rates since its introduction in 2001. In combination with Dr. Eid’s
self-developed “no-touch” surgical technique, which eliminates direct
and indirect contact between the prosthesis and the patient’s skin
(the origin of most infections), he believes the new coating will
offer additional protection against the most common pathogens
responsible for sphincter infections.

Dedicated to Patient Education

Dr. Eid has developed a website http://www.urologicalcare.com
dispelling common misconceptions about penile implant surgery. Having
performed over 3,000 penile implant surgeries (the most worldwide),
Dr. Eid knows what a remarkable and positive difference the treatment
can make in a man’s life. Between retaining a normal penis look and
feel, employment of multiple techniques for preventing infection, and
steady diminishment of pain until it is completely gone within 2-4
weeks, penile implant surgery has proven to be an effective treatment
for many men, resulting in normal, healthy and productive lives.

About J. Francois Eid, M.D, and urologicalcare.com

Dr. Eid is the director and founder of Advanced Urological Care in
New York City. He is also a Clinical Associate Professor of Urology
at Cornell University. Dr. Eid is one of the foremost specialists in
urological prosthetic reconstruction and performs over 300 internal
penile implants per year. Dr. Eid leads workshops on penile
prosthesis surgeries worldwide. More information about Dr. Eid and
his expertise with erectile dysfunction treatment, penile prosthesis
implantations and artificial urinary sphincters can be found on his
website, http://www.urologicalcare.com.

Urologicalcare.com

Men who experience erectile dysfunction between the ages of 40 and 49 are twice as likely to develop heart disease than men without dysfunction, according to a new Mayo Clinic study.

Researchers also found that men with erectile dysfunction have an 80 percent higher risk of heart disease.

“The highest risk for coronary heart disease was in younger men,” says researcher Jennifer St. Sauver, Ph.D. The study was published in the February 2009 issue of Mayo Clinic Proceedings. The results suggest that younger men and their doctors may need to consider erectile dysfunction a harbinger of future risk of coronary heart disease — and take appropriate steps to prevent it, says Dr. St. Sauver.

“The importance of the study cannot be overstated,” writes Martin Miner, M.D., in an editorial in the same issue of Mayo Clinic Proceedings. The results “raise the possibility of a ‘window of curability,’ in which progression of cardiac disease might be slowed or halted by medical intervention,” writes Dr. Miner, who practices at the Men’s Health Center, Miriam Hospital, Providence, R.I.

Erectile dysfunction is common, and prevalence increases with age. It affects 5 to 10 percent of men at age 40. By age 70, from 40 to 60 percent of men have the condition.

Dr. St. Sauver says researchers wanted to learn more about the connections between age, cardiovascular disease and erectile dysfunction. Two previous studies, both published in 2005, laid groundwork for the Mayo Clinic study. One found that erectile dysfunction predicted an increased risk of heart disease, but the erectile dysfunction of the study participants was not assessed with an externally validated questionnaire and cardiac events were not subjected to standardized review for diagnostic accuracy [Thompson et al, JAMA, 2005]. The second predicted that future cardiovascular disease would be higher in younger men with erectile dysfunction, but wasn’t able to follow the men to determine if heart disease developed [Ponholzer et al, Eur Urol, 2005].

For the Mayo Clinic study, the investigators identified 1,402 men who lived in Olmsted County, Minn., in 1996 and did not have heart disease. Every two years for 10 years, these men were assessed for urological and sexual health.

Answers to questions from the Brief Male Sexual Function Inventory, a statistically validated questionnaire, were used to determine erectile dysfunction. The baseline prevalence of erectile dysfunction in study participants was: 2.4 percent in men aged 40-49; 5.6 percent in men aged 50-59; 17 percent in men aged 60-69 and 38.8 percent in men 70 years and older. Those initial data and the increasing incidence of erectile dysfunction over time were linked to data from a long-term study of heart disease in Olmsted County residents, led by Veronique Roger, M.D., Mayo Clinic cardiologist.

Over 10 years of follow-up, researchers found that men with erectile dysfunction were 80 percent more likely to develop coronary heart disease compared to men without erectile dysfunction. The highest risk of new heart disease was seen in the youngest study participants who had erectile dysfunction. In men 40 to 49 years old when the study began, the number of new cases in men with erectile dysfunction was more than 50-fold higher than in men without erectile dysfunction. Statistically, that’s a cumulative incidence of 48.52 per 1,000 person years in those with erectile dysfunction compared to 0.94 per 1,000 person years in those without erectile dysfunction.

In men in their 50s, 60s and 70s, the total incidence of new cases of heart disease also was higher in those with erectile dysfunction. However, the differences were not as striking as those seen among the 40- to 49-year- olds.

“In older men, erectile dysfunction may be of less prognostic importance for development of future heart disease,” says Dr. St. Sauver.

This study did not determine reasons for the increased risk of heart disease among men with erectile dysfunction. Some have theorized that erectile dysfunction and coronary artery disease may be different manifestations of the same underlying disease process. A buildup of plaque that can block arteries around the heart may plug the smaller penile arteries first, causing erectile dysfunction. Alternatively, arteries may lose elasticity over time, contributing to heart disease. This arterial stiffening may affect the smaller penile arteries first.

Other Mayo Clinic researchers were: Brant Inman, M.D.; Debra Jacobson; Michaela Mc Gree; Ajay Nehra, M.D.; Michael Lieber, M.D.; Dr. Roger; and Steven Jacobsen, M.D., Ph.D.

A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at http://www.mayoclinicproceedings.com.

To obtain the latest news releases from Mayo Clinic, go to http://www.mayoclinic.org/news. MayoClinic.com (http://www.mayoclinic.com) is available as a resource for your health stories.

Mayo Clinic
http://www.mayoclinic.com

A new robotic surgical technique developed at The Cancer Institute of New Jersey (CINJ) for the removal of all or part of the prostate gland is showing what investigators call a “dramatic improvement” in a male’s sexual potency rate. The results were recently presented at the 26th World Congress Endourology meeting in Shanghai, China. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School and has also developed a Center of Excellence for robotic surgery.

Robotic prostatectomy allows a surgeon to control a set of robotic arms that holds the surgical instruments in order to remove prostate cancer through several incisions that are smaller than a quarter. It allows for additional precision, reduced blood loss, shorter hospital stays and faster recovery for the patient. Isaac Kim, MD, PhD, who is the director of CINJ’s Urologic Oncology Program and assistant professor of surgery at UMDNJ-Robert Wood Johnson Medical School, found a way to enhance the procedure, by developing a new technique known as Athermal Intrafascial Robotic (AIR) prostatectomy.

In AIR prostatectomy, the nerve that controls a man’s ability to have an erection is better preserved by sparing over 90 percent of the tissues that surrounds the prostate. In the conventional open or robotic radical prostatectomy, typically only 40 to 50 percent of the tissue around the prostate is spared. Additional tissues that are located at the top of the prostate are nearly impossible to spare during an open prostatectomy due to the presence of a major vein called the dorsal venous complex.

Typically with the conventional method, the sexual potency rate is between 65 and 75 percent at one year following the surgery. With the AIR procedure, investigators at CINJ found the potency level was at 91 percent nine months post surgery. At the nine-month mark for the conventional robotic method, the potency rate was only 67 percent.

Dr. Kim, who has performed more than 450 robotic prostatectomies over the past four years at CINJ’s Flagship hospital, Robert Wood Johnson University Hospital in New Brunswick, notes the results are significant, “Not only does the AIR procedure help men regain sexual function in a quicker fashion, but it also helps them to regain control over their bladder faster as well as reducing incontinence.”

At six months, the continence rate (defined as requiring no protective pads) following the AIR procedure was 93 percent.

About The Cancer Institute of New Jersey

The Cancer Institute of New Jersey is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School. To support CINJ, please call the Cancer Institute of New Jersey Foundation at 1-888-333-CINJ.

The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Affiliate Hospitals: Bayshore Community Hospital, Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, CentraState Healthcare System, Cooper University Hospital*, Jersey Shore University Medical Center, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter’s University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate

Michele Fisher
Media Relations Specialist
Office of Communications
The Cancer Institute of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903
http://www.cinj.org